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Hypertension: FDA has approved Bystolic, a beta-blocker


The FDA ( Food and Drug Administration ) has approved Bystolic ( Nebivolol ), a beta blocker, for the treatment of high blood pressure.

The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.

A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control.

In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.

The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea.

Nearly one in three adults in the United States has hypertension, which can increase the risks for stroke, heart failure, myocardial infarction, kidney failure, and death.

Source: FDA, 2007

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